Infliximab dosing based on blood concentrations in patients with sarcoidosis: smart dosing

• Conditions: Sarcoidosis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-002224-26-NL
• Lead Sponsor: St. Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-03
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

patients diagnosed with sarcoidosis being treated with infliximab or with an indication for infliximab

capability of giving informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•vaccination with live viral or bacterial vaccines within the previous 3 months, or with the last dose within the previous 3 months
•active or untreated latent tuberculosis (by mantoux-Elispot/TBC-IGRA)
•serious infections within the last 2 months
•serious right ventricular heart failure or cor polmunale
• Active hepatitis B
history of allergic reactions to monocolonal antibodies or their fragments

oppotunistic infections with the last 6 months

HIV

transplantation

known malignancy

pregnancy or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change from baseline at week 26.;Secondary Objective: To compare both treatment strategies in terms of FVC change from baseline at week 50, DLCO change from baseline at week 26 and 50. <br><br>To compare both treatment strategies in terms of X-Thorax, HRCT and PET activity change from baseline at week 26 and 50.<br><br>To compare both treatment strategies in terms of sIL2R, ACE concentration change from baseline at week 26 and 50.<br><br>To compare both treatment strategies in terms of changes in 6MWT, quality of life and fatigue at several time points.<br><br>To compare both treatment strategies in terms of safety e.g. development of infections and infusion reactions.<br>;Primary end point(s): FVC at week 26.<br><br>;Timepoint(s) of evaluation of this end point: week 26.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Symptoms, CRP-, ACE-, sIL2R-concentrations at week 0, 14, 26 and 50.<br>Lung function i.e. FVC and DLCO at week 0, 26 and 50.<br><br>Imaging: X-Thorax, HRCT and PET scanning at week 0, 26 and 50.<br><br>Endpoints in terms of Quality of Life are measurements obtained with EuroQol 5D and SF36 questionnaires at week 0, 14, 26 and 50.<br><br>Endpoints in terms of fatigue are measurements obtained with Checklist Individual Strength (CIS) at week 0, 14, 26 and 50.<br><br>Safety endpoints such as infusion reactions, infections.<br>;Timepoint(s) of evaluation of this end point: Depends on endpoint; at several of the following timepoints i.e. 0, 14, 26 and 50 weeks